📢 Exciting News from Soleno Therapeutics! 🎉Soleno announced today the company has officially submitted a New Drug Application (NDA) to the FDA for DCCR (diazoxide choline) extended-release tablets. This new treatment targets Prader-Willi syndrome (PWS) in individuals aged 4 and older with hyperphagia. CEO Anish Bhatnagar, M.D., says, “This milestone brings us closer to offering a new therapeutic for PWS. We extend our gratitude to everyone involved in the DCCR development program.” With Breakthrough, Fast Track, and Orphan Drug Designations, Soleno hopes for a Priority Review to expedite the FDA's process. Read the full press release at https://lnkd.in/gTXcnRpR. #SolenoTherapeutics #PraderWilliSyndrome #DCCR #FDA #MedicalBreakthrough
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Amazing news!!!
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3moExciting news for the Prader-Willi community. Best wishes on priority review!